Evidence map›Paper›PMID 37607780›Full record

Trial reportLupus science & medicine2023

Anifrolumab in lupus nephritis: results from second-year extension of a randomised phase II trial.

David Jayne, Brad Rovin, Eduardo Mysler, Richard Furie, Frédéric Houssiau, Teodora Trasieva, Jacob Knagenhjelm, Erik Schwetje, Weifeng Tang, Raj Tummala and 1 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Lupus science & medicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02547922 (A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 2 Study Evaluating the Efficacy and Safety of Anifrolumab in Adult Subjects With Active Proliferative Lupus Nephritis), which is not on this map. Cited by 31 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
31citing papers in PubMed, 1 pooled it
10.2field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02547922 phase2completednot on this map

A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase 2 Study Evaluating the Efficacy and Safety of Anifrolumab in Adult Subjects With Active Proliferative Lupus Nephritis

TypeinterventionalSponsorAstraZenecaRan2015 to 2021Enrolled147ConditionsLupus NephritisArmsAnifrolumab, Placebo
3 · Its place in the literature

Who cites it

31 citing papers in PubMed, 1 synthesis or guideline pooled it, 41 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 6 institutions in 4 countries.

David JayneDepartment of Medicine, University of Cambridge, Cambridge, UK.ORCID 0000-0002-1712-0637
Brad RovinDepartment of Internal Medicine-Nephrology, The Ohio State University, Columbus, Ohio, USA.ORCID 0000-0001-5639-0210
Eduardo MyslerRheumatology, Organizacion Medica de Investigacion SA, Buenos Aires, Argentina.ORCID 0000-0002-8993-0313
Richard FurieDivision of Rheumatology, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Great Neck, New York, USA.ORCID 0000-0001-6712-1585
Frédéric HoussiauRheumatology Department, Cliniques universitaires Saint-Luc, Institut de Recherche Expérimentale et Clinique, Universite catholique de Louvain, Brussels, Belgium.ORCID 0000-0003-1451-083X
Teodora TrasievaBioPharmaceuticals R&D, AstraZeneca, Goteborg, Sweden.
Jacob KnagenhjelmBioPharmaceuticals R&D, AstraZeneca, Goteborg, Sweden.
Erik SchwetjeBioPharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland, USA.
Weifeng TangBioPharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland, USA.
Raj TummalaBioPharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland, USA.
Catharina LindholmBioPharmaceuticals R&D, AstraZeneca, Goteborg, Sweden Catharina.Lindholm@astrazeneca.com.
AstraZeneca (Sweden) · SEAstraZeneca (United States) · USCliniques Universitaires Saint-Luc · BEDonald & Barbara Zucker School of Medicine at Hofstra/Northwell · USThe Ohio State University · USUniversity of Cambridge · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo characterise the safety and efficacy of anifrolumab in active lupus nephritis (LN) through year 2 of the phase II randomised, double-blind Treatment of Uncontrolled Lupus via the Interferon Pathway (TULIP)-LN trial (NCT02547922) of 2 anifrolumab dosing regimens versus placebo.

methodsPatients received intravenous anifrolumab 900 mg for the first 3 doses followed by 300 mg anifrolumab (intensified regimen (IR)), 300 mg anifrolumab (basic regimen (BR)) or placebo every 4 weeks throughout. To continue into Year 2, patients must have achieved at least partial renal response and a glucocorticoid tapering target.

resultsOf 147 randomised patients, 101 completed Year 1 study treatment; of these, 75 (74%) continued into Year 2 (anifrolumab IR: n=29, BR: n=23 and placebo: n=23). During Year 2, 72% of patients reported ≥1 adverse event (AE); serious AEs were reported in 6.9%, 8.7% and 8.7% of patients (anifrolumab IR, BR and placebo, respectively); 3 patients discontinued treatment due to an AE (anifrolumab IR: n=2 and placebo: n=1) and herpes zoster was reported in 2 patients (anifrolumab IR: n=1 and BR: n=1). The study was ongoing at the start of the pandemic, but no COVID-19 cases were reported. Of the 145 patients receiving treatment, more patients on the IR attained complete renal response at Week 104 compared with those on BR or placebo (27.3% vs 18.6% and 17.8%) and simultaneously achieved sustained glucocorticoid tapering (IR: 25.0%; BR: 18.6% and placebo: 17.8%). The improvements in estimated glomerular filtration rate were numerically larger in both anifrolumab groups versus placebo.

conclusionsThe safety and tolerability profile through Year 2 of TULIP-LN was generally consistent with Year 1, with promising efficacy results for the anifrolumab IR regimen. Collectively, the results support further investigation of an anifrolumab intensified dosing regimen in larger populations of patients with active proliferative LN. TRIAL REGISTRATION NUMBER: NCT02547922.

Indexed as

Lupus Erythematosus, SystemicLupus NephritisAntibodies, Monoclonal, HumanizedGlucocorticoidsHumansKidneyanifrolumabAntibodies, Monoclonal, HumanizedGlucocorticoidsautoimmune diseaseslupus nephritistherapeutics

Identifiers

PMID37607780
PMCPMC10445374
OpenAlexW4386083776

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.